Evidence-based practice

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. Good surgeons use both individual clinical expertise and the best available external evidence, as neither alone is enough. Without the current best evidence, surgical practice risks becoming rapidly out-of-date to the detriment of patients.

Evidence-based surgery is not restricted to randomised trials and meta-analyses but involves tracking down the best external evidence available to answer clinical questions or problems (see Box 1.1). For example, to find out about the accuracy of a diagnostic test, we need to find proper, cross-sectional studies of patients clinically suspected of harbouring the relevant problem and not a randomised trial. Proper follow-up studies of patients inform about prognosis. Systematic review of several randomised trials (meta-analysis) is much more likely to inform about therapy and whether it does more good than harm.

Evidence-based medicine is a relatively young discipline whose positive impacts are just beginning to be validated, and it will continue to evolve. These days, several undergraduate and postgraduate continuing medical education programmes adopt it and adapt it to their learners’ needs, providing further information and understanding about what evidence-based medicine is and what it is not.

Clinical governance and audit

Patient safety: the WHO surgical safety checklist

This simple yet effective tool has been introduced around the world by the World Health Organisation and is thought to have already saved many lives (Fig. 1.1).

Figure 1.1 The WHO Surgical Safety Checklist

(from The WHO Surgical Safety Checklist, World Health Organisation 2009, with permission.)

Peer review

This is a system whereby hospitals or units are scrutinised by independent peers who assess systems and processes against a set of bench marks for diagnosis and treatment, e.g. for cancer.

The reasons for audit include time utilisation/cost-effectiveness, mortality/morbidity assessment, ensuring quality of diagnostic services, monitoring performance, assessment of newer technologies, knowledge of patient satisfaction, exploration of legal implications and research. Research asks, ‘Are we doing the right operation?’ Audit research asks, ‘Are we doing the operation right?’

For audit to be meaningful, it should satisfy the following criteria:

• includes open debate and self-evaluation

• confidentiality of surgeon and patient maintained

• demonstration of change resulting in improvement of patient care

• resources spent are kept to a minimum

• standards set and reviewed periodically

• priority topics audited

• interesting and informative.

The audit cycle involves observation of existing practice, the setting of standards, comparison between observed and set standards, implementation of change, and re-audit of clinical practice (Fig. 1.2).

Figure 1.2 The audit cycle.

Audit techniques available include morbidity and mortality, incident review (critical incident reporting), clinical record review, adverse occurrence screening, focused audit studies, global audit (comparison between units), and national studies, for example the National Confidential Enquiry into Patient Outcome and Death (NCEPOD).

The essential features of audit include high-quality data collection, relevant and valid measures of outcome, appropriate and valid measures of case mix, a representative population and appropriate statistical analysis.

Accountability

As surgeons, we are accountable to our patients to inform them about their conditions, educate them about the risks and benefits of their choices, and suggest to them what we would do for ourselves. We then respect their decisions about their own care. It is an essence of our professional life and the basis for our relationship with patients.

At every level of healthcare, the system should be accountable to patients. This demands that patients have access to the information, education and support they need to manage their own healthcare. It also places demands upon patients, holding them responsible for at least a portion of their healthcare decisions and requiring them to be responsible for the consequences of personal decisions that place them at higher risk for illness and disability, e.g. cigarette smoking, alcohol consumption, and obesity (diet).

Informed consent

Informed consent is the process by which fully informed patients can participate in choices about their healthcare. It originates from the legal and ethical right the patient has to direct what happens to his or her body and the ethical duty of the surgeon to involve the patient in his or her healthcare.

Complete informed consent includes a discussion of the following:

In order for the patient’s consent to be valid, he or she must be considered competent to make the decision at hand and consent must be voluntary. To encourage the ‘voluntariness’, the surgeon can emphasise that the patient is participating in a decision, not just signing a form. Comprehension on the part of the patient is as important as the information given. Consequently, the discussion should be carried out in lay person’s terms and the patient’s understanding should be assessed along the way. This should be done by a surgeon who is competent to do the surgery, within the clinic or ward environment prior to any move toward theatre. Consent taken within a few minutes of surgery is not valid.

Legal aspects of surgical practice

Every surgeon must expect to be the subject of complaint or legal claim from time to time, and be prepared to justify why they have managed the patient in the way that they have. Good surgical practice is defensible practice. This depends on staying within the limits of your expertise, keeping up to date and conducting audit (see above), ensuring effective administration and communicating effectively with patients, their carers and colleagues and ensuring that medical records recall all salient facts relating to the patient. If things go wrong be honest, investigate the facts, explain the situation fully to the patient and do not be afraid to apologise.

While clinical standards continue to improve, complete eradication of error is not possible and there is no foolproof way that surgeons can avoid being litigated against.

Administration

The surgeon has a responsibility to ensure that basic systems are in place to deal with patient referral, follow-up, completion of clinical records, correspondence, review of test results and appropriate action taken on discovery of abnormalities. He or she should not rely on administrators for this purpose. Communication skills have been mentioned in terms of informed consent, but it is also vital to ensure good communication between teams and, in particular, between primary and secondary care.

Medical record-keeping is vital and it is essential that each patient contact is adequately recorded so that all clinical developments are noted, together with investigations and actions on results, and that notes for future management, referral and follow-up are recorded. Notes should include a history, examination of the patient, diagnosis, information conveyed to the patient, consent obtained, treatment, follow-up and progress – in a legible form – so that the patient’s care can be picked up by other colleagues.

When things go wrong, the surgeon must readily provide a prompt, open, constructive and honest response to any complaint about the patient’s care. Where appropriate, an apology should be given. You must co-operate with any further enquiry into the treatment of the patient. You must give (to those who are entitled to ask for it) any relevant information in connection with an investigation into your own or another healthcare professional’s conduct, performance or health. Surgeons who prevaricate, appear evasive or refuse to acknowledge fault are far more likely to push their patients towards litigation than those who explain exactly what happened, and apologise for any shortcomings on their part. Patients who are entitled to compensation should receive this swiftly and fairly. It is the surgeon’s responsibility to make sure he is adequately insured against the possibility of litigation. Although in the UK a surgeon’s NHS practise is indemnified, the terms are limited; ‘good Samaritan’ acts are not covered for instance.

Breaking bad news

Breaking bad news to patients is a common part of surgical life, particularly for those surgeons involved in cancer medicine. The following framework is suggested and many courses are now available to clinicians to practise this skill.

Continuing professional development and revalidation

It is essential to keep up to date with current practice; the most obvious example of which is the ‘MDT’ or multi-disciplinary meeting, an integral part of the management of cancer cases.

There has always been an expectation that the surgeon should actively keep abreast of developments in his or her field, and refresh skills/knowledge – a process known as continuing professional development (CPD). There are a multitude of courses available, although funding is always an issue.

A more formal process known as ‘revalidation’ (the process by which licensed doctors will, in future, regularly demonstrate to the General Medical Council in the UK that they are up to date and fit to practise) is expected to begin in late 2012. It is proposed that each doctor will need to maintain a dossier of ‘supporting information’ (e.g. CPD course details) which will form the basis of their annual appraisal, with a ‘responsible officer’ such as a medical director making a recommendation of fitness to practise every five years.